Approved GLP-1 medicine

Semaglutide

Sold as Ozempic, Wegovy, Rybelsus. Also called NN9535, NNC 0113-0217.

Semaglutide copies a gut hormone called GLP-1. It helps the pancreas release insulin when blood sugar is high, slows the stomach a little, and quiets hunger signals in the brain. A fatty side chain lets it stick to a blood protein, so it lasts about a week in the body. It is approved medicine.

How strong is the evidence?

AnecdoteAnimalsHuman trialsApproved

Approved. Approved by a major regulator after large trials.Approved by the FDA (Ozempic 2017, Rybelsus 2019, Wegovy 2021; MASH indication 2025; Wegovy tablet December 2025) and by the EMA (Ozempic 2018, Rybelsus 2020, Wegovy 2022). Evidence comes from large randomised, placebo-controlled phase 3 trials: SUSTAIN-6 (3,297 people with type 2 diabetes), STEP 1 (1,961 adults with overweight or obesity), SELECT (17,604 adults with heart disease and overweight or obesity, no diabetes), FLOW (3,533 people with type 2 diabetes and chronic kidney disease) and ESSENCE part 1 (800 people in the interim analysis). All were funded by Novo Nordisk.

Last verified 2026-09-29 · how we verify

Experimental structure

Experimental structure · cryo-EM 2.5 Å · PDB 7KI0 (2021)RCSB entry ↗

Semaglutide peptide chain and part of its linker (PDB component WF1) are modelled; the C18 fatty diacid is not resolved. Nanobody Nb35 (chain N), used to stabilise the complex, is omitted. Structure from Zhang et al., Cell Rep 2021. Colours are ours, not the molecule's.

Acts on: GLP-1 receptor
Taken as: Approved as a once-weekly subcutaneous injection (Ozempic, Wegovy) or as a once-daily oral tablet co-formulated with SNAC (Rybelsus, Ozempic tablets, Wegovy tablets), prescribed and supervised by a clinician.
Half-life: About 1 week (elimination half-life); the drug stays in the blood for about 5 weeks after the last injection[src]
FDA approval, Ozempic: Original FDA approval on 5 December 2017 (injection, type 2 diabetes).[src]
FDA approval, Wegovy: Original FDA approval on 4 June 2021 (injection, chronic weight management).[src]
FDA approval for MASH: On 15 August 2025 the FDA granted Wegovy accelerated approval for noncirrhotic MASH with moderate to advanced liver fibrosis; a study to confirm clinical benefit is ongoing.[src]

Inside the body

What Semaglutide does, step by step

Watch the 3D journey →

01Bloodstream
Rides on albumin in the blood
After an injection, semaglutide slips into the blood. Its fatty tail sticks to albumin, a common blood protein. That protects it from being broken down and from leaving through the kidneys, so it lasts about a week.
For experts
The C18 fatty diacid on Lys26 mediates albumin binding (>99% bound), reducing renal clearance and protecting against metabolic degradation; Aib8 confers DPP-4 stability. Volume of distribution is about 12.5 L, clearance about 0.05 L/h, and elimination half-life about 1 week. The design was published in the discovery paper, where the plasma half-life in mini-pigs after intravenous dosing was 46.1 h (animal data).[src][src]
02Pancreas
Helps the pancreas release insulin
When blood sugar is high, semaglutide tells the pancreas to release more insulin and less glucagon, a hormone that raises blood sugar. When blood sugar is not high, this effect is small.
For experts
Semaglutide selectively binds and activates the GLP-1 receptor, stimulating insulin secretion and lowering glucagon secretion in a glucose-dependent manner. The cryo-EM structure of the receptor-Gs complex (PDB 7KI0) shows the receptor in its active, G-protein-coupled state.[src][src]
03Stomach
Slows the stomach a little
Food may leave the stomach a bit more slowly, mostly right after a meal. Over months of use, this slowing seems to get smaller.
For experts
The label describes a minor delay in gastric emptying in the early postprandial phase. In a 20-week placebo-controlled study of semaglutide in 72 adults with obesity, paracetamol absorption over 5 hours after a meal (an indirect gastric-emptying measure) rose 8% (P=0.005), not significant after adjusting for body weight (P=0.12), with no effect over the first hour. The authors concluded there was no evidence of delayed gastric emptying at week 20 by this indirect measure, so the effect appears small with continued use.[src][src]
04Brain
Quiets hunger signals in the brain
GLP-1 receptors sit in parts of the brain that help control appetite. In people, semaglutide made hunger weaker and fullness stronger, and people ate less at a test meal. Animal studies show where in the brain it acts.
For experts
Human data: in a placebo-controlled study, semaglutide reduced ad libitum energy intake by 35% at week 20, reduced hunger and prospective food consumption, and increased fullness and satiety. Animal-only data: in rodents, semaglutide did not cross the blood-brain barrier but reached the brainstem, septal nucleus and hypothalamus through circumventricular organs and sites next to the ventricles, activated c-Fos in 10 brain areas, and lowered body weight without lowering energy expenditure. The label states the GLP-1 receptor is present in brain areas involved in appetite regulation, and that animal studies show semaglutide activates neurons there.[src][src][src]
05Fat tissue
Eating less leads to weight loss
Because people feel less hungry and eat less, most lose body weight over time, mainly by losing body fat. In the main weight trial, average weight loss was about 15% with semaglutide and about 2% with placebo.
For experts
In STEP 1 (1,961 adults with overweight or obesity, 68 weeks, plus lifestyle intervention), mean body-weight change was -14.9% with semaglutide versus -2.4% with placebo (difference -12.4 percentage points). 86.4% versus 31.5% lost at least 5%, 69.1% versus 12.0% at least 10%, and 50.5% versus 4.9% at least 15%. Weight loss is understood to follow reduced energy intake; STEP 1 is a human trial and is not a fat-tissue mechanism study.[src]
06Heart
Lowers the risk of heart events in some people
In big trials, adults with heart disease or high heart risk who took semaglutide had fewer major heart events (heart attacks, strokes and heart-related deaths, counted together) than those on placebo. Scientists have not yet proven exactly why.
For experts
SUSTAIN-6 (type 2 diabetes, 104 weeks): primary composite outcome in 6.6% versus 8.9%, hazard ratio 0.74 (95% CI 0.58 to 0.95). SELECT (heart disease and overweight or obesity without diabetes, mean follow-up 39.8 months): 6.5% versus 8.0%, hazard ratio 0.80 (95% CI 0.72 to 0.90). The label states the exact mechanism of cardiovascular risk reduction has not been established.[src][src][src]
07Kidneys
Protects the kidneys in diabetes with kidney disease
In people with type 2 diabetes and long-term kidney disease, semaglutide lowered the chance of serious kidney problems and of dying from heart-related causes compared with placebo.
For experts
FLOW (3,533 participants with type 2 diabetes and CKD; median follow-up 3.4 years; stopped early at a prespecified interim analysis): major kidney disease events in 331 versus 410 first events, hazard ratio 0.76 (95% CI 0.66 to 0.88; P=0.0003); annual eGFR decline slower by 1.16 mL/min/1.73 m2. The label states the mechanism of kidney-related risk reduction has not been established.[src][src]
08Liver
Improves liver inflammation and scarring in MASH
In people with a fatty-liver disease called MASH and moderate to advanced scarring, semaglutide cleared liver inflammation more often than placebo and reduced scarring in more people. How it does this is not fully known.
For experts
ESSENCE part 1 (800 patients, week 72 interim analysis, biopsy-defined MASH with fibrosis stage 2 or 3): steatohepatitis resolution without worsening fibrosis in 62.9% versus 34.3%; fibrosis reduction without worsening steatohepatitis in 36.8% versus 22.4%. The FDA approved this indication in August 2025 under accelerated approval; continued approval may depend on a confirmatory trial showing clinical benefit. The label says the precise mechanism in humans is not fully understood and may involve weight loss and other pathways; mouse-model liver improvements are animal-only evidence.[src][src]

For experts

The detail

Semaglutide is a GLP-1 receptor agonist: a 31-residue peptide analogue with 94% sequence homology to human GLP-1, with its peptide backbone made by yeast fermentation (C187H291N45O59, 4113.58 g/mol). Three changes drive its profile: Aib at position 8 (stabilises it against DPP-4), Arg at position 34 (so only one lipid attaches), and a C18 fatty diacid on Lys26 via a hydrophilic spacer, which binds albumin (>99% bound) and lowers renal clearance. Subcutaneous bioavailability is 89%, peak levels come 1 to 3 days after a dose, and the elimination half-life is about 1 week, with steady state after 4 to 5 weeks. Tablets are co-formulated with the absorption enhancer SNAC; the label estimates absolute bioavailability at about 0.4% to 1% for Rybelsus and 1% to 2% for Ozempic tablets. It is approved by the FDA and EMA (Ozempic and Rybelsus for type 2 diabetes; Wegovy for weight management, with FDA-approved cardiovascular risk reduction and, under accelerated approval, MASH). Key trials: SUSTAIN-6 (cardiovascular outcomes in type 2 diabetes), STEP 1 (weight), SELECT (cardiovascular outcomes without diabetes), FLOW (kidney outcomes) and ESSENCE (MASH).

Evidence: Approved by the FDA (Ozempic 2017, Rybelsus 2019, Wegovy 2021; MASH indication 2025; Wegovy tablet December 2025) and by the EMA (Ozempic 2018, Rybelsus 2020, Wegovy 2022). Evidence comes from large randomised, placebo-controlled phase 3 trials: SUSTAIN-6 (3,297 people with type 2 diabetes), STEP 1 (1,961 adults with overweight or obesity), SELECT (17,604 adults with heart disease and overweight or obesity, no diabetes), FLOW (3,533 people with type 2 diabetes and chronic kidney disease) and ESSENCE part 1 (800 people in the interim analysis). All were funded by Novo Nordisk.[src][src][src][src][src][src][src][src][src][src][src][src][src][src]

Known safety signals

Boxed warning: in rodents semaglutide caused dose- and duration-dependent thyroid C-cell tumours at clinically relevant exposures. Whether it does so in humans is unknown. It is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with MEN 2.[src]
Gastrointestinal effects are the most common adverse reactions. In the pooled weight-management trials of Wegovy injection versus placebo, nausea occurred in 44% versus 16%, diarrhoea 30% versus 16%, vomiting 24% versus 6% and constipation 24% versus 11%.[src]
The label warns of acute pancreatitis, acute gallbladder disease (cholelithiasis in 1.6% of adults on Wegovy injection versus 0.7% on placebo in weight-reduction trials), acute kidney injury from volume depletion, and hypersensitivity reactions.[src]
In SUSTAIN-6, diabetic retinopathy complications were higher with semaglutide than placebo (hazard ratio 1.76; 95% CI 1.11 to 2.78) in people with type 2 diabetes at high cardiovascular risk.[src]
Because semaglutide delays gastric emptying, there are rare post-marketing reports of pulmonary aspiration during general anaesthesia or deep sedation in people taking GLP-1 receptor agonists.[src]
Compounded semaglutide products are not FDA-approved. As of 31 May 2026 the FDA had received 990 adverse-event reports associated with compounded semaglutide. The FDA notes these events are likely underreported, because federal law does not require state-licensed pharmacies that are not outsourcing facilities to report them.[src]

Around the world

Is Semaglutide legal where you live?

Country	Status	What it means	Verified
Australia	Approved	Approved on the ARTG as Ozempic, Rybelsus and Wegovy. PBS covers Ozempic for type 2 diabetes; Wegovy is not yet PBS-listed. Compounded copies barred since 1 Oct 2024.Details →source	2026-09-29
Brazil	Approved	Approved as Ozempic, Rybelsus and Wegovy, with Brazilian-made versions approved from May 2026Details →source	2026-09-29
Canada	Generics available	Approved as Ozempic, Rybelsus and Wegovy; generic semaglutide approved from April 2026 and on sale since May 2026Details →source	2026-09-29
China	Approved	Approved in China as an imported brand; domestic generics are still waiting for approval.Details →source	2026-09-29
European Union	Approved	Authorised EU-wide for type 2 diabetes, weight management and MASH (Ozempic, Rybelsus, Wegovy, Kayshild)Details →source	2026-09-29
India	Generics available	Approved in India (Novo Nordisk's Wegovy and type 2 diabetes products); Indian generics on sale since March 2026, prescription-onlyDetails →source	2026-09-29
Japan	Approved	Approved for type 2 diabetes (Ozempic, Rybelsus) and obesity (Wegovy); Wegovy use is limited by an MHLW guidelineDetails →source	2026-09-29
Mexico	Approved	Approved in Mexico as Ozempic, Rybelsus and Wegovy; generic applications are pending but none is registeredDetails →source	2026-09-29
New Zealand	Approved	Approved as Wegovy for weight management and heart-risk reduction; not publicly fundedDetails →source	2026-09-29
United Arab Emirates	Approved	Approved: Wegovy (injection and, since June 2026, a daily pill) for weight management, Ozempic for type 2 diabetes; prescription-onlyDetails →source	2026-09-29
United Kingdom	Approved	Licensed in the UK: Ozempic and Rybelsus for type 2 diabetes, Wegovy for weight management (now also as a tablet)Details →source	2026-09-29
United States	Approved	FDA-approved as Ozempic, Rybelsus and Wegovy; compounded copies lost their shortage cover in 2025 and 503B is proposing a formal exclusionDetails →source	2026-09-29

Who makes it

Novo NordiskDanish drugmaker that markets semaglutide (as Ozempic, Wegovy, Rybelsus and the Wegovy pill) and liraglutide (as Victoza and Saxenda) for type 2 diabetes and weight management. Its pipeline also includes cagrilintide (with semaglutide as CagriSema, for which the company listed a US regulatory decision as an upcoming milestone in its August 2026 report) and amycretin (called zenagamtide in its 2026 reports), which are investigational. Novo Nordisk files annual reports and quarterly announcements with the U.S. Securities and Exchange Commission, and its own figures are quoted below.

Recent history

2026-09-18
Health Canada approves Sandoz's generic semaglutide
2026-07-21
Novo Nordisk sues Eli Lilly over GLP-1 advertising
2026-07-01
Medicare GLP-1 Bridge set to start, with a $50 co-pay for eligible weight-management prescriptions
2026-06-11
UK MHRA approves the first GLP-1 tablet for weight loss
2026-04-30
FDA proposes to bar bulk compounding of semaglutide, tirzepatide and liraglutide by outsourcing facilities
2026-04-28
Health Canada approves the first generic semaglutide, a generic Ozempic from Dr. Reddy's
2026-04-21
CMS delays the Medicare part of the BALANCE model and extends the GLP-1 Bridge through 2027
2026-03-31
US Customs reports about 5,000 mis-manifested peptide shipments seized in Cincinnati

Full timeline →

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